Varian cage
FDA 510(k) K172756 · Medyssey USA, Inc.
510(k) numberK172756
Submission
- Device name
- Varian cage
- Applicant
- Medyssey USA, Inc.
Elk Grove Village, IL, US - Received
- September 13, 2017
- Decision date
- December 8, 2017
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MAX – Intervertebral Fusion Device With Bone Graft, Lumbar
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3080
- Specialty
- Orthopedic
- Implant
- Yes
Intended to stabilize spinal segment to promote fusion in order to restrict motion and decrease pain using bone graft.
Other 510(k)s with product code MAX
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|---|---|---|---|
| K261049 | Scala® TLMAX · Traditional | Spineart SA | 08/20/2026SE |
| K261430 | TruLift Expandable SystemMAX · Traditional | Life Spine, Inc. | 07/28/2026SE |
| K253011 | Catalyft PL Expandable Interbody SystemMAX · Traditional | Medtronic Sofamor Danek USA, Inc. | 07/17/2026SE |
| K261020 | Symmetrix L Spinal SystemMAX · Traditional | Medtronic Sofamor Danek USA, Inc. | 07/14/2026SE |
| K253420 | Admiral ACP System; Explorer TO System; Laminoplasty System; Manta Ray TDF Spacer…MAX · Traditional | SeaSpine Orthopedics Corporation | 07/01/2026SE |
| K253151 | Fule Interbody Fusion Cage SystemMAX · Traditional | Beijing Fule Science & Technology Development… | 06/15/2026SE |
| K261159 | Exceed® Biplanar Expandable Interbody SystemMAX · Traditional | Spine Wave, Inc. | 05/29/2026SE |
| K253894 | BMD Titanium Spinal Fusion SystemMAX · Traditional | Global Biomedica s.r.o. | 05/28/2026SE |
| K260506 | Ventana® P/T Lumbar Interbody SystemMAX · Traditional | Spinal Elements, Inc. | 05/15/2026SE |
| K260837 | VersaLift Expandable SystemMAX · Traditional | Life Spine, Inc. | 05/12/2026SE |
More from Life Spine, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K232218 | Zenius Spinal SystemNKB · Special | 08/24/2023SE |
| K230301 | Athena III Cervical Plate SystemKWQ · Special | 03/07/2023SE |
| K223654 | Medussa-PL CageMAX · Special | 12/28/2022SE |
| K200283 | Medussa-PL CageMAX · Special | 06/18/2020SE |
| K183407 | Triton CageMAX · Traditional | 08/30/2019SE |
| K183409 | Athena II Cervical Plate SystemKWQ · Traditional | 02/11/2019SE |
| K181978 | Zenius, Iliad and Kora Spinal Fixation SystemsNKB · Special | 08/13/2018SE |
| K180022 | Athena Cervical Plate SystemKWQ · Traditional | 07/20/2018SE |
| K170389 | TAURUS PEEK Cage SystemMAX · Traditional | 12/14/2017SE |
| K170341 | Medussa-PL CageMAX · Traditional | 11/02/2017SE |
Questions and answers
When was Varian cage cleared by the FDA?
Varian cage (K172756) received a 510(k) decision of Substantially Equivalent on December 8, 2017, 86 days after the submission was received.
What is the product code of K172756?
The FDA product code is MAX – Intervertebral Fusion Device With Bone Graft, Lumbar, a Class II (moderate risk) device regulated under 21 CFR 888.3080.